Study to Assess the Efficacy and Safety of SK-MS10 in Subjects With Acute and Chronic Gastritis

SK chemicals

Status and phase: Completed; Phase 2

Conditions: Erosive Gastritis

Treatments: Drug: Placebo; Drug: SK-MS10

Study type: Interventional

Funder types: Industry

Identifiers

NCT01578811

SK-MS10_GID_II_2010

Details and patient eligibility

About

The purpose of this study is to Assess the Efficacy and Safety of SK-MS10 in subjects With acute and chronic gastritis.

Enrollment: 102 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have been diagnosed as erosive gastritis by endoscopy within 1 weeks before enrollment.
2. Patients who voluntarily signed written informed consent may participate in the study.

Exclusion criteria

1. Pregnant or lactating female.
2. Patients have gastric ulcer, duodenal ulcer and GERD.
3. Use of any proton pump inhibitor, H2-receptor antagonist, muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study drug therapy
4. Patients requiring corticosteroid therapy
5. Severe neurological or psychological disease
6. History of allergic reaction to the medications used in this study
7. Use of other investigational drugs within 30 days prior to the study.
8. Patients that investigators consider ineligible for this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

SK-MS10 160mg t.i.d

Experimental group

Treatment:

Drug: SK-MS10

Drug: SK-MS10

SK-MS10 320mg t.i.d

Experimental group

Treatment:

Drug: SK-MS10

Drug: SK-MS10